ADEMETIONINE IN TREATMENT OF DRUG INDUCED LIVER INJURY: AN OBSERVATIONAL STUDY IN RUSSIAN PATIENTS, RECEIVING IMMUNOSUPPRESSIVE THERAPY FOR PSORIASIS

Background: Drug induced liver injury (DILI), especially; due to use of immunosuppressive agents is a growing concern. Lack of awareness about available treatment options limits its management. This observational study was conducted to characterize Russian population receiving ademetionine as a hepatoprotectant against DILI triggered due to immunosuppressive drugs. Methods: A total of 105 patients having DILI with cholestasis (by immunosuppressives) aged 18-65 years were enrolled in a multicentric, non-interventional, prospective observational study. The study had three phases (Start up: Ademetionine intravenous/intramuscular 400-800 mg/day, 2 weeks; Maintenance: 800-1600 mg/day, 4 weeks, orally; Follow up: At end of 4 weeks post-treatment). Profiling of patients, reasons for prescribing ademetionine and safety parameters were assessed. Changes from baseline in the levels of laboratory parameters, signs and symptoms of cholestasis and depressed mood were also assessed. Results: All enrolled patients were Caucasian (44.4 years; smokers: 41.9%; consumed alcohol daily: 31.4%; history of psoriasis: 86.7%). Methotrexate was the most commonly used immunosuppressive agent (used in 80.0% of patients). Post treatment with ademetionine, levels of various laboratory parameters (bilirubin, alkaline phosphatase, γ-glutamyl transpeptidase, alanine transaminase, aspartate transaminase) significantly decreased P< 0.05. Symptoms of intrahepatic cholestasis (IHC) such as pruritus, fatigue and jaundice improved and number of patients with depressive symptoms decreased (baseline: 92 [87.6%]; Day 42: 27 [25.7%]). No adverse events were reported.Conclusions: In patients with immunosuppressant induced DILI and cholestasis, psoriasis was the most common underlying disorder. Treatment with ademetionine demonstrated beneficial effects in liver disease with improvement in laboratory parameters and symptoms of IHC